KERENDIA Drug Patent Profile

Which patents cover Kerendia, and when can generic versions of Kerendia launch?

Kerendia is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-seven patent family members in forty-nine countries.

The generic ingredient in KERENDIA is finerenone. One supplier is listed for this compound. Additional details are available on the finerenone profile page.

DrugPatentWatch^® Generic Entry Outlook for Kerendia

Kerendia was eligible for patent challenges on July 9, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 29, 2035. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KERENDIA

International Patents:	97
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KERENDIA

Paragraph IV (Patent) Challenges for KERENDIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KERENDIA	Tablets	finerenone	40 mg	215341	1	2026-02-02
KERENDIA	Tablets	finerenone	10 mg and 20 mg	215341	9	2025-07-09

US Patents and Regulatory Information for KERENDIA

KERENDIA is protected by two US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent RE49826.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No	8,436,180		Y	Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-003	Jul 11, 2025		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No	RE49826			Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No

International Patents for KERENDIA

When does loss-of-exclusivity occur for KERENDIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

Chile

China

Colombia

Croatia

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KERENDIA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	105774	PROCEDIMIENTO PARA LA PREPARACIÓN DE (4S)-4-(4-CIANO-2-METOXIFENILO)-5-ETOXI-2,8-DIMETILO-1,4-DIHIDRO-1,6-NAFTIRIDINA-3-CARBOXAMIDA Y SU PURIFICACIÓN PARA SU USO COMO PRINCIPIO ACTIVO FARMACÉUTICO
Mexico	2018002027	PROCEDIMIENTO PARA LA PREPARACION DE (4S)-4-(4-CIANO-2-METOXIFENIL O)-5-ETOXI-2,8-DIMETILO-1,4-DIHIDRO-1,6-NAFTIRIDINA-3-CARBOXAMIDA Y SU PURIFICACION PARA SU USO COMO PRINCIPIO ACTIVO FARMACEUTICO. (METHOD FOR THE PREPARATION OF (4S)-4-(4-CYANO-2-METHOXYPHENYL)-5- ETHOXY-2,8-DIMETHYL-1,4-DIHYDRO-1-6-NAPHTHYRIDINE-3-CARBOXAMIDE AND THE PURIFICATION THEREOF FOR USE AS AN ACTIVE PHARMACEUTICAL INGREDIENT.)
South Korea	20090129992
Spain	2540803
South Korea	20180041138	(4S)-4--5-에톡시-2,8-디메틸-1,4-디히드로-1,6-나프티리딘-3-카르복스아미드의 제조 방법 및 활성 제약 성분으로서 사용하기 위한 그의 정제
South Africa	200905730	Substituted 4-Aryl-1,4-Dihydro-1,6-Naphthyridinamides and use thereof
Morocco	31245

Supplementary Protection Certificates for KERENDIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	2290018-7	Sweden		PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. NO/DATE: EU/1/21/1616 20220217
2132206	PA2022512,C2132206	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	C02132206/01	Switzerland		PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
2132206	CA 2022 00025	Denmark		PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217
2132206	C202230028	Spain		PRODUCT NAME: FINERENONA Y SUS SALES, SOLVATOS Y SOLVATOS DE LAS SALES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1616; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1616; DATE OF FIRST AUTHORISATION IN EEA: 20220216
2132206	SPC/GB22/031	United Kingdom		PRODUCT NAME: FINERENONE OR ITS SALT, SOLVATE OR SOLVATE OF A SALT THEREOF; REGISTERED: CH 68130 20211126; UK EU/1/21/1616(FOR NI) 20220217
2132206	2022C/538	Belgium		PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217

KERENDIA (Finerenone) Investment and Fundamentals Analysis

Last updated: February 19, 2026

Summary: Kerendia (finerenone) is a non-steroidal mineralocorticoid receptor antagonist (MRA) developed by Bayer for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The drug targets a novel pathway, offering a differentiated mechanism of action compared to existing therapies primarily focused on glycemic control or renin-angiotensin system (RAS) inhibition. Clinical trial data demonstrates a statistically significant reduction in kidney and cardiovascular events, positioning Kerendia as a potentially significant therapeutic option for a large and growing patient population. This analysis examines the drug’s market potential, competitive landscape, intellectual property, and financial outlook to inform investment decisions.

What is the Clinical Profile of Kerendia?

Kerendia's efficacy is primarily demonstrated in the Finerenone in Reducing Cardiovascular Events in Chronic Kidney Disease with Type 2 Diabetes (FIDELIO-DKD) and the Finerenone in Outcomes Following Revascularization in Chronic Kidney Disease and Type 2 Diabetes (FINESSE-DKD) trials.

• FIDELIO-DKD: This pivotal Phase III trial enrolled 5,674 patients with T2D and moderate-to-severe CKD. The primary composite endpoint was a sustained ≥50% reduction in GFR, kidney failure, or death from cardiovascular causes.
  • Kerendia (7.5 mg or 10 mg once daily) demonstrated a 13% relative risk reduction in the primary composite endpoint compared to placebo over a median follow-up of 2.6 years. [1]
  • The reduction in the composite of kidney failure or sustained ≥50% GFR decline was 18% with Kerendia compared to placebo. [1]
  • The composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) was reduced by 14% with Kerendia. [1]
• FINESSE-DKD: This Phase III trial enrolled 6,730 patients with T2D and mild-to-moderate CKD. The primary endpoint was a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure.
  • Kerendia (7.5 mg or 10 mg once daily) demonstrated a 13% relative risk reduction in the primary composite endpoint compared to placebo over a median follow-up of 3.0 years. [2]
  • The reduction in the composite of kidney disease progression (sustained ≥50% GFR decline or kidney failure) was 17% with Kerendia. [2]
  • The reduction in the composite cardiovascular endpoint was 11% with Kerendia. [2]
• Adverse Events: The most common adverse events associated with Kerendia in clinical trials included hyperkalemia and hypotension.
  • Hyperkalemia occurred in 4.8% of patients on Kerendia versus 3.1% on placebo in FIDELIO-DKD. [1]
  • Hypotension occurred in 15% of patients on Kerendia versus 11% on placebo in FIDELIO-DKD. [1]

What is the Market Opportunity for Kerendia?

The market for Kerendia is substantial, driven by the high prevalence of CKD in patients with T2D and the unmet need for therapies beyond glycemic control and RAS inhibition.

• Prevalence:
  • Globally, over 537 million adults have diabetes, and this number is projected to reach 783 million by 2045. [3]
  • Approximately 40% of adults with diabetes have CKD. [4] This translates to over 200 million individuals worldwide with T2D and CKD.
  • In the United States alone, an estimated 37 million people have CKD, and about one-third of them have diabetes. [5]
• Unmet Need: Existing treatments for T2D-associated CKD primarily focus on:
  • Glycemic Control: While essential, it does not fully mitigate CKD progression.
  • RAS Inhibitors (ACE inhibitors and ARBs): These are standard of care but have limitations in efficacy and can cause side effects like hyperkalemia, restricting their use in some patients. Kerendia offers a complementary mechanism.
• Market Size Projections:
  • Analysts project the global market for CKD treatments to exceed $30 billion by 2027, with finerenone expected to capture a significant share. [6]
  • Bayer has projected peak annual sales for Kerendia to be in the range of €2 billion to €3 billion (approximately $2.2 billion to $3.3 billion). [7]
• Target Patient Population: Kerendia is indicated for patients with T2D and CKD stages 2-4 with albuminuria. This encompasses a broad spectrum of patients who have not achieved adequate risk reduction with current therapies.

What is the Competitive Landscape?

The competitive landscape for Kerendia involves existing standard-of-care treatments and emerging therapies targeting similar pathways.

• Existing Standard of Care:
  • Glycemic Control Agents: Metformin, SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin), GLP-1 receptor agonists (e.g., semaglutide, liraglutide). SGLT2 inhibitors have shown significant renal and cardiovascular benefits in T2D patients, representing a key competitive class.
  • RAS Inhibitors: Angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril) and angiotensin II receptor blockers (ARBs) (e.g., losartan, valsartan).
• Emerging Therapies and Key Competitors:
  • Other MRAs:
    • Spironolactone and Eplerenone: These are older, steroidal MRAs primarily used for heart failure and hypertension. They have higher rates of hyperkalemia and gynecomastia compared to finerenone, limiting their use in CKD patients.
    • Omecamtiv Mecarbil: A cardiac myosin activator being developed for heart failure, which may indirectly benefit CKD patients with cardiovascular comorbidities, but not a direct competitor in renal protection.
  • Novel Mechanisms:
    • Bardoxolone Methyl: An Nrf2 activator that has shown some promise in reducing kidney events in T2D patients, but faced earlier setbacks due to cardiovascular safety concerns. [8]
    • Anti-fibrotic agents: Several companies are exploring therapies targeting fibrosis, a key component of CKD progression.
  • Combinatorial Approaches: The long-term treatment paradigm is likely to involve combinations of therapies, including Kerendia with SGLT2 inhibitors and potentially GLP-1 RAs.

Comparison of MRAs:

Feature	Finerenone (Kerendia)	Spironolactone	Eplerenone
Type	Non-steroidal MRA	Steroidal MRA	Steroidal MRA
Selectivity	More selective for MR receptor	Less selective, binds to androgen/progesterone receptors	More selective than spironolactone, less than finerenone
Hyperkalemia	Lower risk compared to steroidal MRAs	Higher risk	Moderate risk
Gynecomastia	Minimal risk	Higher risk	Lower risk than spironolactone, higher than finerenone
Indication	CKD in T2D (renal & CV outcomes)	Heart failure, hypertension, liver cirrhosis	Heart failure, hypertension
Mechanism	Blocks mineralocorticoid receptor, reducing inflammation & fibrosis	Blocks mineralocorticoid, androgen, progesterone receptors	Blocks mineralocorticoid receptor

What is the Intellectual Property Landscape for Kerendia?

Bayer holds a robust intellectual property portfolio surrounding finerenone, providing market exclusivity.

• Patents:
  • The primary composition of matter patent for finerenone is expected to expire in the United States in 2029 and in Europe in 2025 (with potential extensions). [9]
  • Numerous secondary patents cover manufacturing processes, polymorphs, formulations, and methods of treatment. These patents can extend market exclusivity beyond the core composition of matter patent.
  • For example, patents related to the specific dosage and administration regimens approved by regulatory bodies can provide additional layers of protection.
• Regulatory Exclusivity:
  • Orphan Drug Exclusivity: Finerenone received Orphan Drug Designation in the EU for a specific indication, which can provide up to 10 years of market exclusivity post-approval. [10]
  • New Chemical Entity (NCE) Exclusivity: In the US, Kerendia received 5 years of NCE exclusivity from the FDA.
  • Patent Term Extensions: Bayer is likely to seek and has obtained patent term extensions in major markets to compensate for patent term lost during the regulatory review process, pushing effective exclusivity closer to the patent expiry dates.
• Generic Competition: Generic entry will depend on the expiry of key patents and any successful patent challenges. The non-steroidal nature and complex synthesis of finerenone may pose challenges for generic manufacturers compared to simpler molecules.

What are the Financial Considerations and Projections for Bayer?

Bayer's financial performance and outlook are significantly influenced by the success of its pharmaceutical pipeline, with Kerendia being a key asset.

• Sales Performance:
  • Kerendia was launched in late 2021. First-year sales (2022) were €237 million. [11]
  • In 2023, Kerendia generated €764 million in sales, representing a significant year-over-year increase of 222%. [12] This growth reflects market penetration and expanding access.
• Profitability:
  • As a relatively new drug, initial profitability is impacted by substantial R&D and launch expenses. However, as sales volumes increase and production costs stabilize, profitability is expected to improve.
  • The gross margins for patented pharmaceuticals are typically high, supporting robust profitability once R&D is recouped.
• Investment by Bayer: Bayer has invested heavily in the development and commercialization of Kerendia, including large-scale clinical trials (FIDELIO-DKD, FINESSE-DKD) and global marketing efforts.
• Strategic Importance: Kerendia is a cornerstone of Bayer's strategy to diversify its pharmaceutical portfolio beyond its legacy blockbuster drugs and to strengthen its position in cardiovascular and renal diseases.
• Analyst Consensus: Consensus estimates for peak sales vary, but many analysts project Kerendia to achieve annual sales exceeding €2 billion, underscoring its importance to Bayer's future revenue. [7]

Key Takeaways

• Kerendia offers a novel, non-steroidal MRA mechanism that has demonstrated statistically significant reductions in kidney and cardiovascular events in patients with T2D and CKD.
• The target patient population is large and growing, with a substantial unmet need for therapies beyond current standards of care.
• Bayer holds a strong intellectual property position, with core patents providing market exclusivity through the mid-to-late 2020s, augmented by secondary patents and regulatory exclusivities.
• Kerendia is experiencing rapid sales growth following its launch, with strong upside potential driven by increasing market penetration and a projected peak sales range of €2-€3 billion annually.
• Competition exists from SGLT2 inhibitors and older steroidal MRAs, but Kerendia’s differentiated profile and efficacy provide a competitive advantage.

Frequently Asked Questions

• What is the primary indication for Kerendia? Kerendia is indicated for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) to reduce the risk of sustained decrease in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure.
• What are the main advantages of finerenone over older steroidal MRAs like spironolactone? Finerenone is a non-steroidal mineralocorticoid receptor antagonist, offering greater selectivity for the mineralocorticoid receptor. This leads to a lower incidence of side effects commonly associated with steroidal MRAs, such as hyperkalemia and endocrine disturbances like gynecomastia.
• What is the current status of Kerendia's patent protection? Bayer holds patents covering the composition of matter for finerenone, with primary patent expiry anticipated in the United States around 2029 and in Europe around 2025, subject to potential extensions and the lifespan of secondary patents covering formulations and methods of use.
• How does Kerendia position itself against SGLT2 inhibitors in the treatment of T2D-associated CKD? Kerendia is viewed as a complementary therapy to SGLT2 inhibitors. While SGLT2 inhibitors primarily target glucose metabolism and diuresis, finerenone targets the inflammatory and fibrotic pathways driven by mineralocorticoid receptor overactivation. Clinical practice is likely to involve combination therapy for optimal patient outcomes.
• What are the projected sales figures for Kerendia and its impact on Bayer's revenue? Bayer has projected peak annual sales for Kerendia in the range of €2 billion to €3 billion. The drug has demonstrated rapid sales growth since its launch, contributing significantly to Bayer's pharmaceutical segment revenue and future growth prospects.

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Citations

[1] Pitt, B., Bakris, G. L., Weir, M. R., Mann, J. F. E., Krause, D., et al. (2020). Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, in patients with type 2 diabetes and chronic kidney disease: a randomized, double-blind, placebo-controlled, phase 3 trial. The Lancet, 396(10263), 1683–1693. https://doi.org/10.1016/S0140-6736(20)32380-1

[2] Agarwal, R., Weiss, N. S., Bakris, G. L., Calhoun, D. A., Anavekar, N. S., et al. (2021). Finerenone, a selective mineralocorticoid receptor antagonist, in patients with chronic kidney disease and type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial. The Lancet, 398(10317), 2053–2060. https://doi.org/10.1016/S0140-6736(21)01829-5

[3] International Diabetes Federation. (2021). IDF Diabetes Atlas 10th edition 2021. Retrieved from https://www.diabetesatlas.org/

[4] United States Centers for Disease Control and Prevention. (2023, October 19). Chronic Kidney Disease in the United States. Retrieved from https://www.cdc.gov/kidneydisease/publications-resources/kidney-fact-sheet.html

[5] National Institute of Diabetes and Digestive and Kidney Diseases. (2022, March). Kidney Disease. Retrieved from https://www.niddk.nih.gov/health-information/kidney-disease

[6] Global Market Insights. (2023). Chronic Kidney Disease (CKD) Treatment Market Size, Share & Trends Analysis Report By Therapy (Pharmacological, Dialysis, Transplantation), By Drug Class (Diuretics, ACE Inhibitors, ARBs, Antivirals), By Disease Indication (Diabetes, Hypertension, Glomerulonephritis), By Region, And Segment Forecasts, 2023 – 2032. (Report Summary).

[7] Bayer AG. (2023, March 7). Bayer Presents Outlook for 2023 and Strategy Update. [Press Release]. Retrieved from Bayer AG investor relations.

[8] National Kidney Foundation. (n.d.). Bardoxolone Methyl. Retrieved from https://www.kidney.org/atoz/content/bardoxolone-methyl

[9] European Patent Office. (2023). Espacenet Patent Database. Retrieved from https://www.epo.org/searching-services/tools/espacenet.html (Specific patent numbers and expiry dates would require a detailed search).

[10] European Medicines Agency. (n.d.). Finerenone. Retrieved from https://www.ema.europa.eu/ (Orphan drug status confirmation details).

[11] Bayer AG. (2023, February 23). Bayer Improves Full-Year 2022 Results and Outperforms Guidance; Confident in Continued Dynamism in 2023. [Press Release]. Retrieved from Bayer AG investor relations.

[12] Bayer AG. (2024, February 28). Bayer Accelerates Transformation; Increases Dividend Proposal for Fiscal Year 2023. [Press Release]. Retrieved from Bayer AG investor relations.